Trials / Unknown
UnknownNCT05146245
Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- Erasmus Medical Center · Academic / Other
- Sex
- All
- Age
- 6 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to test whether therapeutic drug monitoring of risperidone in children with autism spectrum disorder and comorbid behavioral problems is able to reduce metabolic side effect burden, while retaining clinical effectiveness.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Therapeutic Drug Monitoring | Physician receives dosing advice based on risperidone plasma level. |
| OTHER | Risperidone plasma level | Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot. |
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2024-05-01
- Completion
- 2024-05-01
- First posted
- 2021-12-06
- Last updated
- 2023-12-08
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05146245. Inclusion in this directory is not an endorsement.